Biofrontera(BFRI)2024-11-14 20:02Financial Data and Key Metrics Changes - Revenues in Q3 2024 increased by 1.5% to $9 million compared to Q3 2023, with a potential growth of 19% if not for shipping delays due to Hurricane Milton [9][23] - For the first nine months of 2024, total revenues grew by $1.3 million to $24.8 million, representing a 5.6% increase [10][29] - The net loss for Q3 2024 was $5.7 million, an improvement from a net loss of $6.3 million in Q3 2023 [27] - Adjusted EBITDA for Q3 2024 was negative $4.6 million, compared to negative $3.9 million in Q3 2023 [28] Business Line Data and Key Metrics Changes - Sales of Ameluz were impacted by a net decrease of $0.5 million in Q3 2024, primarily due to delayed shipments [23] - The RhodoLED XL lamp contributed an increase of $600,000 in device sales in Q3 2024 [23] - Total operating expenses for Q3 2024 were $14 million, up from $13.5 million in Q3 2023, driven by increased costs associated with the RhodoLED product [25] Market Data and Key Metrics Changes - The FDA approved the use of up to three tubes of Ameluz per treatment, which is expected to enhance market penetration and convenience for healthcare providers [12] - The company anticipates a significant increase in Ameluz usage following the recent FDA approval and improved reimbursement conditions [19] Company Strategy and Development Direction - The company is focusing on expanding the indications for Ameluz, including moderate-to-severe acne, which is seen as a potential blockbuster market [14] - Biofrontera has taken control of all clinical trial activities for Ameluz in the U.S., which is expected to enhance profitability and bring the breakeven point closer [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth due to the increase in Ameluz tubes ordered and the positive clinical results [50] - The company expects to achieve cash flow breakeven towards the end of 2025 into 2026, with revenue growth projected in the mid- to high teens for 2024 [37] Other Important Information - The company has successfully reduced inventory levels closer to industry standards, with cash and cash equivalents increasing to $2.9 million as of September 30, 2024 [33] - The XEPI product is being evaluated for potential disposition, with the asset moved to held for sale [34] Q&A Session Summary Question: When will the cost of revenue start to better reflect the 25% that is valid through next year? - Management expects to see that impact in the fourth quarter as they needed to go through older inventory [36] Question: Do you still expect to be cash flow breakeven by the end of next year and to grow revenue this year by 20% over 2023? - Management expects revenue growth similar to prior years, in the mid- to high teens, and cash flow breakeven is anticipated towards the end of 2025 into 2026 [37] Question: Did the shipments that fell into October stick with the October 1 price hike? - Management confirmed that the older price was grandfathered in for the orders placed in Q3 [39] Question: Can you provide enrollment numbers for the acne and peripheral AK trials? - Enrollment for the peripheral AK trial is 130 of 165 patients, and for the acne study, it is 106 of 126 [39] Question: How do you see the fourth quarter developing in terms of revenue after the price increase? - Management expects a very strong Q4, traditionally the strongest quarter, despite the price increase [42][44] Question: Have you seen any customer response to the new labeling for the three-tube approval? - Management has not yet promoted the new labeling but plans to do so soon, anticipating an uptake in December [46]